Director, Clinical Development – MD

Stellenbeschreibung:

Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease
Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials
Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents
Participate in investigator meetings, site engagement activities, and selected site initiation activities
Support execution of clinical development plans by identifying study risks, proposing mitigations, and tracking milestones, deliverables, and budget-conscious study decisions
Interpret research, translational, and nonclinical findings and translate them into clinical development opportunities
Interact with investigators, key opinion leaders, and external experts
Partner with Regulatory Affairs, Safety, Clinical Operations, Biometrics, Translational Sciences, Medical Writing, and other functions
Provide clinical input to regulatory submissions and responses to health authority questions for INDs and clinical trial applications
Contribute clinical guidance in interactions with advisory boards, patient advocacy organizations, and internal stakeholders
Present scientific or clinical data at investigator meetings and scientific congresses and contribute to abstracts, presentations, and publications
Support due diligence or clinical evaluation of external opportunities as needed

Requirements

MD or DO required
Approximately 2 to 5 years of clinical, scientific, and/or drug development experience in biopharma, academia, healthcare, or related settings
Working knowledge of clinical trial design, protocol development, safety review, and Good Clinical Practice
Ability to function effectively in a matrixed, cross-functional team environment
Board certified or board eligible in Neurology
Training and clinical expertise in neurology, neuroimmunology, or autoimmune neurologic disease
Drug development experience in neurology, autoimmune disease, cell therapy, immunology, or other advanced therapeutics
Experience supporting Phase 1, Phase 1b/2, or proof-of-concept studies
Demonstrated ability to contribute to study design, study conduct, and emerging data interpretation
Strong clinical judgment, scientific rigor, and problem-solving skills
Effective written and verbal communication skills
Ability to work with appropriate independence while escalating issues thoughtfully
Ability to build productive working relationships with internal colleagues, investigators, and key thought leaders
Comfort operating in a fast-paced and evolving development environment
May travel up to 25%

Core Competencies

Demonstrates expertise in clinical trial design, protocol development, and regulatory submissions, with a strong focus on neurology and autoimmune diseases. Proven ability to collaborate effectively in cross-functional teams while maintaining scientific rigor and clinical judgment.

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